Cross-Framework Mapping

ISO/IEC 27011:2024vsICH E6(R3) - Good Clinical Practice

See exactly how ISO/IEC 27011:2024 controls map to ICH E6(R3) - Good Clinical Practice. Pre-computed mappings, identified gaps, and coverage analysis.

9
Controls Mapped
35
Gaps Found
16%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27011:2024 maps to ICH E6(R3) - Good Clinical Practice with 16% coverage across 9 directly mapped controls. Analysis of 44 ISO/IEC 27011:2024 controls identifies 41 compliance gaps — primarily concentrated in Technological.

Source: TheArtOfService Knowledge Graph | 44 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 9 of 9 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 1-4: Introduction and Framework(3 mappings)

27011-1Scope
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
27011-3Terms and definitions
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
27400-3Terms and definitions
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation

Organisational(1 mappings)

27011-5.2Information Security Roles in Telecoms
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

Clause 5: Organizational Controls for Telecommunications(1 mappings)

27011-5.2Information Security Roles in Telecoms
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

People(1 mappings)

27011-6.3Awareness and Training
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

Clause 6: People Controls for Telecommunications(1 mappings)

27011-6.3Awareness and Training
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

Clause 8: Technological Controls for Telecommunications(2 mappings)

27011-8.4Logging and monitoring
ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrityICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity
27011-8.6Data protection and backup
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

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What are the key differences between ISO/IEC 27011:2024 and ICH E6(R3) - Good Clinical Practice?

ISO/IEC 27011:2024 has 44 controls across its framework, while ICH E6(R3) - Good Clinical Practice covers 9 controls. Direct mapping analysis identifies 9 overlapping controls (16% coverage). The frameworks diverge most significantly in Technological, where 11 ISO/IEC 27011:2024 controls have no direct ICH E6(R3) - Good Clinical Practice equivalent.

How many controls map between ISO/IEC 27011:2024 and ICH E6(R3) - Good Clinical Practice?

Of 44 total ISO/IEC 27011:2024 controls, 9 map directly to ICH E6(R3) - Good Clinical Practice controls — representing 16% coverage. The remaining 41 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27011:2024 to ICH E6(R3) - Good Clinical Practice?

41 ISO/IEC 27011:2024 controls have no direct equivalent in ICH E6(R3) - Good Clinical Practice. The highest concentration of gaps is in Technological with 11 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between ISO/IEC 27011:2024 and ICH E6(R3) - Good Clinical Practice?

The domain with the highest gap count is Technological (11 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.